Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
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Purpose
This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant recipient population, our study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Immunosuppression |
Procedure: Gastric emptying test |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study to Evaluate Tolerability of Myfortic With Simulect Induction and Tacrolimus Without Steroids in Three Patient Populations; 1: Kidney/Pancreas Transplants,2: Diabetic Kidney Transplants, and 3: Non-diabetic Kidney Transplants |
- Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids [ Time Frame: 24 months ] [ Designated as safety issue: No ]Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects
- GI complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]Gastric emptying test
- Graft function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Renal function assessed by serum creatinine and calculating creatinine clearance.
Pancreas function assessed by glucose control, exogenous insulin requirement, HgbA1C
- Biopsy proven rejection [ Time Frame: 24 months ] [ Designated as safety issue: No ]Renal graft core biopsy will be performed on all suspected rejection.
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Transplant recipients
All subjects receive identical drug treatment
|
Procedure: Gastric emptying test
Gastric emptying tests will be performed at baseline, 6 months and 12 months
Other Names:
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Detailed Description:
Myfortic® is an enteric-coated formulation of the sodium salt derivative of mycophenolic acid (MPA) that is administered to control kidney graft rejection. Myfortic® was developed to improve MPA-related upper gastrointestinal (GI) side effects by delaying the release of MPA until it reaches the large surface of the small bowel. Approximately half of all the kidney transplant recipients in the United States have diabetes mellitus. A recent analysis of approximately 30,000 kidney transplant recipients included in the U.S. Renal Data System showed that 42% of patients had pre-transplant diabetes (1). Moreover, 15% to 20% of patients develop diabetes after transplantation, a condition that is commonly known as post-diabetes mellitus (1-3). It was previously shown that the rate and extent of MPA absorption is minimally affected by diabetes (4). Limited data is available in the current literature on Myfortic® and Simulect® based therapy in diabetic patients.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.
- Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated)
- Written inform consent obtained. The patients are willing to participate in the study at UTMB.
- Female with negative pregnancy test.
- PRA < 20 %.
- En-blocks and two kidneys (tx'd at the same time) will be allowed.
- Cold Ischemia time ≤ 30 hrs
- Hep C patients will be allowed to enroll in this study
Exclusion Criteria:
- Multi-organ transplants
- Transplant from non-heart beating donor (NHBD) or dual transplants
- A-B-O incompatible or positive cross match
- Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications.
- Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding
- Inability to tolerate oral medications
- Inability to sign a written consent form or to cooperate with investigators
- Use of an investigational medication in the past 30 days.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- HIV positive patients
- History of psychosocial instability
- Mental incompetence
Contacts and Locations| Contact: Luca Cicalese, MD | 4097722412 | lucicale@utmb.edu |
| Contact: Betty Shipp, RN | 4097724896 | bjshipp@utmb.edu |
| United States, Texas | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77555 | |
| Contact: Luca Cicalese, MD 409-772-2412 lucicale@utmb.edu | |
| Contact: Betty Shipp, RN 4097724896 bjshipp@utmb.edu | |
| Sub-Investigator: Cristiana Rastellini, MD | |
| Sub-Investigator: Fernando Cesani, MD | |
| Sub-Investigator: Tina Kochar, MBBS | |
| Sub-Investigator: Shilpa Rastogi, MD | |
| Principal Investigator: | Luca Cicalese, MD | University of Texas |
More Information
No publications provided
| Responsible Party: | The University of Texas, Galveston |
| ClinicalTrials.gov Identifier: | NCT01387659 History of Changes |
| Other Study ID Numbers: | 10-244 |
| Study First Received: | June 8, 2011 |
| Last Updated: | June 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas, Galveston:
|
Myfortic Simulect Steroids Diabetes |
Transplant Gastric emptying Gastric motility |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Mycophenolic Acid Mycophenolate mofetil Tacrolimus Basiliximab Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013